Aurorix 300 mg film-coated tablets – moclobemide for major depression and social phobia

Aurorix is a medicine containing the active substance moclobemide, an antidepressant from the group of reversible inhibitors of monoamine oxidase type A (RIMA). It increases the amount of important chemical messengers in the brain, which helps treat depression and social phobia.

In Serbia it is authorised as 300 mg film-coated tablets (30 tablets) and is a prescription-only medicine. The 150 mg strength is no longer authorised. The medicine must not be combined with a number of other antidepressants and medicines for pain, cough and migraine, so your doctor and pharmacist need to know about every medicine you take.

What is Aurorix (moclobemide) used for and how should it be taken?

Key facts about the medicine

What is Aurorix used for?

According to the leaflet and Summary of Product Characteristics, Aurorix is used to treat:

• major depression – with symptoms such as marked sadness, low mood, loss of interest and energy, sleep disturbances, feelings of guilt and poor concentration
• social phobia – a marked fear of situations in which others watch or judge you, which interferes with everyday social activities

How is it taken and dosed?

Take the tablet at the end of a meal and swallow it with water; the score line is not intended for breaking. The 150 mg strength is not authorised in Serbia, so 150 mg doses are not possible with the authorised 300 mg tablets – the doctor decides how treatment is started. This is general dosing from the leaflet – your doctor decides your treatment.

Special patient groups

• Elderly patients: no dose adjustment needed.
• Kidney impairment: no dose adjustment needed.
• Liver impairment: the doctor sets the dose, usually lower than those above.
• Children and adolescents: must not be used.

Contraindications – when the medicine must not be used

• hypersensitivity to moclobemide or any of the excipients
• severe mental disorders with confusion or loss of contact with reality
• phaeochromocytoma (adrenal gland tumour)
• current or recent use of other antidepressants and anti-anxiety medicines: fluoxetine, fluvoxamine, paroxetine, clomipramine, venlafaxine, citalopram, escitalopram, sertraline, bupropion
• concomitant use of dextromethorphan, pethidine, tramadol, selegiline, triptans (sumatriptan, rizatriptan, zolmitriptan, almotriptan, naratriptan, frovatriptan, eletriptan) or linezolid
• children and adolescents

Precautions and warnings

• Tell your doctor if you have bipolar disorder, schizophrenia or other mental disorders, if you have ever had suicidal thoughts, an overactive thyroid or serious liver disease.
• Thoughts of self-harm may occur more often at the start of treatment (the effect usually begins after about two weeks) and in young adults (under 25).
• Buprenorphine with Aurorix can cause serotonin syndrome.
• Watch for restlessness, irritability, insomnia, elation and hyperactivity, and for signs of low sodium (drowsiness, confusion, convulsions), especially in the elderly.
• Contains lactose; essentially sodium-free.

Interactions with other medicines, food and drink

• Prohibited combinations: listed under contraindications (other antidepressants, dextromethorphan, pethidine, tramadol, selegiline, triptans, linezolid).
• Tell your doctor if you take: cimetidine, omeprazole, buprenorphine, ephedrine, pseudoephedrine or phenylpropanolamine (cough and cold medicines), opioids (morphine, fentanyl, codeine), trimipramine, maprotiline, phenelzine, tranylcypromine, dextropropoxyphene or sibutramine.
• Herbal products containing St John's wort interact with the medicine.
• Food: do not eat large amounts of tyramine-rich food – fermented cheeses, yeast extract, fermented soya products.

Pregnancy and breast-feeding

There are no adequate data on the safety of moclobemide in pregnancy, and a small amount passes into breast milk. The doctor will assess whether you may take Aurorix during pregnancy or breast-feeding.

Driving and using machines

Aurorix may affect the psychophysical abilities needed for driving and using machines, especially at the start of treatment (triangle warning on the pack).

Possible side effects

• Very common: sleep disturbance, headache, dizziness, dry mouth, nausea.
• Common: nervousness, restlessness, anxiety, irritability, tingling in the arms and legs, low blood pressure, rash, vomiting, diarrhoea, constipation.
• Uncommon: suicidal thoughts, disorientation, taste and visual disturbances, flushing, fluid retention, hives and itching, weakness and tiredness.
• Rare: reduced appetite, low blood sodium, increased liver enzymes, suicidal behaviour, delusions, serotonin syndrome.
• An allergic reaction (swelling of the throat, face, lips, hands or feet, itching, hives) requires stopping the medicine and contacting a doctor immediately.

Report suspected side effects to your doctor, pharmacist or ALIMS.

Overdose, missed dose and stopping treatment

• Overdose causes mild nervous system disturbances and digestive irritation – contact a doctor or the nearest hospital immediately and take the pack with you.
• Missed dose: take it as soon as you remember; if it is nearly time for the next dose, skip the missed one. Do not take a double dose.
• Do not stop treatment without talking to your doctor, even if you feel better.

Related information

A category link has been deliberately omitted: “mood and relaxation” products often contain St John's wort or other substances that interact with moclobemide. For questions about treatment, please ask your doctor or pharmacist.

Composition, packaging and manufacturer

• Active substance: moclobemide 300 mg per film-coated tablet.
• Core: lactose monohydrate, maize starch, povidone K30, sodium starch glycolate (type A), magnesium stearate.
• Film coating: hypromellose, ethylcellulose (aqueous dispersion), macrogol 6000, talc, titanium dioxide (E171).
• Pack: PVC/Al blister of 10 tablets; carton with 3 blisters (30 film-coated tablets).
• Marketing authorisation holder: VIATRIS HEALTHCARE D.O.O., Bulevar Mihajla Pupina 115a, Belgrade – Novi Beograd. Manufacturers: Meda Pharma GmbH & Co. KG (Germany), Cenexi (France), Mylan Hungary Kft. (Hungary).

Storage

• No special storage conditions required.
• Shelf life: 5 years. Keep out of the sight and reach of children.
• Return unused medicine to a pharmacy that collects unused medicines.

Frequently asked questions

Can I take cough syrup while on Aurorix?

Not without checking: dextromethorphan, found in many cough syrups, must not be taken with Aurorix, and your doctor must be told about codeine and cold remedies containing pseudoephedrine or ephedrine.

Do I need to avoid any food?

Do not eat large amounts of tyramine-rich food – fermented cheeses, yeast extract and fermented soya products.

When does it start to work?

Depression takes time – usually about two weeks, with treatment lasting at least 4–6 weeks; for social phobia at least 8–12 weeks.

Is there an Aurorix 150 mg?

No. Only the 300 mg strength is authorised in Serbia; the authorisation for the 150 mg tablets ended in 2022.

Sources

• ALIMS – Summary of Product Characteristics Aurorix® 300 mg film-coated tablets (Serbian)
• ALIMS – Patient leaflet Aurorix® 300 mg film-coated tablets, June 2024 (Serbian)

Sources checked on: 23 October 2026.